Some New Jersey residents may be among those affected by issues with the HeartMate II LVAS Pocket System Controller. After reports of 26 deaths and 19 injuries, the Thoratec Corporation and Abbott Laboratories are recalling the device. Almost 29,000 devices have been removed from the market in what the Food and Drug Administration has classified as the most serious kind of recall.
The Pocket System Controller powers a device that circulates blood throughout a person’s body when the heart cannot do so. It may be connected to a power supply or powered with batteries. There is also a backup controller in case the main one malfunctions. The injuries and deaths occurred when a patient was attempting to switch system controllers. In a total of 70 reports received, after an exchange, there was a malfunction.
According to a letter sent on March 29, 2017, the two companies will take several actions. Patients getting new devices will also receive hardware and software upgrades. Patients who already have devices will receive updated software and alarm guides. The companies will contact affected providers so that software updates, labeling updates and office visits are coordinated.
Products liability refers to the obligation a manufacturer has to make sure a product on the market is reasonably safe when used as directed or that users have adequate warnings about the dangers of the product. People who are injured or made ill by a product when using it correctly may want to speak to an attorney about filing a lawsuit. The injury or illness could result in substantial medical bills. In addition to compensation, a lawsuit might also bring attention to the issues with the product if the company is not responsive about removing it from the market or making it safer.
